1. Technical Field
The present disclosure relates to methods, systems and apparatus for UV light sterilization of container systems and/or container-packaged products, and, more particularly, to systems and methods for monochromatic UV light sterilization of liquid and/or solid products/solutions and/or packaging/container systems for liquid and/or solid products/solutions (e.g., parenteral pharmaceutical products/solutions and/or packaging/container systems for parenteral pharmaceutical products/solutions).
2. Background Art
In general, sterilization is typically defined as the substantially complete destruction of all organisms, including a large number of highly resistant bacterial endospores. Several sterilization techniques have been developed to address specific sterilization needs. For example, some typical sterilization techniques include the use of moist heat from a steam autoclave, ethylene oxide gas sterilizing techniques, dry heat techniques, and newer chemical sterilizers.
One widely used sterilization technique is steam sterilization. In general, steam sterilization is typically viewed as being relatively cost-effective. For example, steam sterilization techniques employing an autoclave are recognized as efficient, simple, and relatively cost-effective approaches for destroying relevant organisms. However, certain components (e.g., some packaging/container system materials and/or products; medical device/instrumentation components and accessories) cannot endure the extremes of heat and/or pressure. For example, steam and pressure are known to risk damage to rubber, Lexan® polycarbonate components, and other synthetic materials. In addition, the use of steam autoclave techniques for anesthesia equipment is generally not recommended, unless the treatment method is specifically recommended by the manufacturer. Moreover, steam sterilization techniques are not readily incorporated into an in-line (i.e., continuous or substantially continuous) process, such as, for example, a packaging/container system filling process. Additionally, typical steam sterilization techniques increase energy costs and generate waste products.
Ethylene oxide is acceptable for many materials used in manufacturing medical devices and the like, such as, for example, the reusable components of anesthesia machines, ventilators, and monitors. However, it is generally inappropriate to place these entire systems in an ethylene oxide chamber. In addition, polystyrene component parts generally should not be exposed to ethylene oxide gas. In general, ethylene oxide sterilization employs a powerful poisonous fumigant gas, and therefore mandates an appropriate means of aeration to remove residual gas. Ethylene oxide has been classified as carcinogenic to humans by the International Agency for Research on Cancer (IARC), and is known to be explosive. Workers exposed to ethylene oxide are required to comply with all procedures specified by OSHA and the EPA. Alternatively, other chemical treatment techniques include the use of hydrogen peroxide and peroxyacetic acid with buffers and low heat.
With reference to the patent literature, a sterilization technique was disclosed in U.S. Pat. No. 5,786,598 to Clark et al., entitled “Sterilization of Packages and Their Contents Using High-Intensity, Short-Duration Pulses of Incoherent, Polychromatic Light in a Broad Spectrum.” As noted in the title, the Clark '598 patent involves the use of high-intensity, short-duration pulses of incoherent, polychromatic light in a broad spectrum to sterilize product containers and deactivate microorganisms therein. The Clark '598 patent proposes “the deactivation of microorganisms within parenteral and/or enteral solutions and packages or within contact lens solutions and packages and/or ophthalmic solutions and packages.” [See col. 1, lines 11-20]. The use of short-duration pulses of incoherent, polychromatic light in a broad spectrum, as disclosed in the Clark '598 patent, is believed to be ineffective and/or unacceptable for at least some aspects of the proposed applications.
Despite efforts to date, a need remains for cost-effective, efficient systems and methods for sterilization of container systems and/or container-packaged products (e.g., liquid and/or solid products/solutions and/or packaging/container systems for liquid and/or solid products/solutions), wherein such sterilization regimen achieves a desired sterilization level without negatively affecting the physical properties of the package/container systems and/or the efficacy of the underlying products/systems. These and other inefficiencies and opportunities for improvement are addressed and/or overcome by the systems and methods of the present disclosure.